Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313177
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures Comparative Study
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ankle fracture is one of the most common orthopedic injuries Approximately 20 of surgically treated ankle fractures are associated with syndesmotic instabilityAccording to the mechanism of the injury the syndesmotic disruption should be considered in Danis-Weber C-type fractures However such injuries were also frequently seen in Danis-Weber B-type fractures Failure to detect and repair syndesmotic injuries early may result in poor clinical outcomes and complications affecting ankle function such as long-term residual pain post traumatic arthritis and ankle impingement syndromes Therefore aggressive treatment is important when facing syndesmotic instability
The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking Syndesmotic injuries are most commonly associated with fibular fractures but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination The need for syndesmotic fixation of the distal tibiofibular joint has been controversia fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally If more than 3 or 4 mm of lateral displacement occurs syndesmotic fixation is necessary
Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complicationsThe main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint The syndesmosis is traditionally fixed with a metallic screw which is a method that has been used for decades and demonstrates good to excellent outcomes
Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of anklein this study we are going to compare between these two
The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking Syndesmotic injuries are most commonly associated with fibular fractures but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination The need for syndesmotic fixation of the distal tibiofibular joint has been controversia fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally If more than 3 or 4 mm of lateral displacement occurs syndesmotic fixation is necessary
Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complicationsThe main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint The syndesmosis is traditionally fixed with a metallic screw which is a method that has been used for decades and demonstrates good to excellent outcomes
Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of anklein this study we are going to compare between these two
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None